QRTI GCP New Page

QRTI Newsline --- Wednesday September 8, 2010

Sponsoring the Training at Investigational Sites

by Rochelle L. Goodson

Is it possible for you to ensure that clinical staff at your Investigational Sites are GCP-trained?

Clinical Management’s mantra for 2009 is "Doing more with less!"

More than ever before, monitors are being required to take on more sites and more protocols. Increased workload has substantially reduced the amount of time a monitor has to educate clinical study staff on GCP procedures or to counsel them with regard to corrective actions. Despite the well established fact that a lack of GCP training usually results in inadequate study conduct and poor record-keeping and source documentation practices, Sponsors and their clinical operations staff often forego GCP training due to the time and money. Lack of site training heightens the risk of poor inspection results due to the increased potential for lack of adequate and accurate efficacy and safety data and the delay of an approval of a submission. Sponsors can avoid all of these negative outcomes by investing in early training, preferably before study start, which will save time and money in the long run. Everyone Benefits

The benefits of sponsored GCP training are many. They include decreasing errors by clinical study staff, decreasing query resolution, decreasing monitoring time due to fewer repeated errors, and avoiding poor study conduct practices that undermine data integrity. Proactive training prevents non-compliances.

The key is to identify crucial areas for key sites and focus on the type and depth of training needed for the specific sites. Consider some of the following benefits derived from Sponsoring the Training at Investigational Sites:

Ensures staff obtain consistent training
Ensures that staff learn and apply regulatory requirements by providing a working knowledge of GCPs
Eliminates problems of the inexperienced that cause serious non-compliances
Optimizes monitoring visits for CRAs and CRCs
Eliminates delinquent/delayed routine efforts
Prepares site personnel in the event of an audit/inspection
Identifies staffing gaps
Assures adequate and/or appropriate delegation of responsibility
Facilitates corrective actions
Promotes understanding of the GCP requirements to eliminate repeat occurrences of problems

Additionally, Sponsors can assure cross site consistency by training all high enrolling sites with the same program. Cost effectiveness is increased with each site added to the program. QRTI’s professional trainers are GCP field-experienced experts and can assist your company in identifying the sites that would benefit most from proactive training of new/inexperienced sites or training sites that are the largest enrolling sites but have demonstrated the need for remediation or retraining.

Both Sponsors and Clinical Investigators have come to expect their CRAs/monitors to also function as GCP trainer. In addition, monitors must accomplish all of the tasks remanded by the FDA regulations and the ICH GCP Guideline. GCP training is never accomplished without forfeiting the time needed to review regulatory documents, study conduct, and clinical data during routine visits. Ultimately, study timelines are constantly revised to compensate. Monitors need to focus on reviewing the data and to assure the collection of adequate and accurate data that permits quick analysis to facilitate submissions.

Build GCP Training into Your Study Budget

Sponsors are being held responsible for inadequate training of protocol-specific procedures, as well as, a lack of adequate experience and GCP training for the conduct of a clinical trial. Recent Form FDA 483 observations and Warning Letters have addressed lack of training as related to poor study conduct, protocol non-adherence, and inadequate and inaccurate recordkeeping. Proactive GCP training of clinical study staff fosters a cooperative, compliance-oriented environment that can protect the subjects, data, PI, site staff and the Sponsor.